Human saliva plays a number of roles in the oral cavity, including aiding in the prevention and healing of infections in the mouth and the remineralization of teeth. Among the components found within human saliva are high concentrations of calcium and phosphate. It is believed that calcium plays a role in preventing oral infection, protecting the oral mucosa and healing wounds in the mouth. Phosphate helps to modulate pH balance in the mouth, protecting the teeth and repairing mucosal damage.
Oral mucositis is a frequent adverse effect from chemotherapy or radiation therapy. Mucositis is painful and can limit adequate nutritional intake and decrease the willingness of patients to continue treatment. More severe mucositis with extensive ulceration may require costly hospitalizations with parenteral nutrition and narcotics. Mucositis may result in serious health complications in addition to the issues for which chemotherapy or radiation was being administered. A mucosal surface that is damaged increases the risk of a secondary infection and may even prove to be an entry point for systemic infection. Mucositis may result in the need to reduce dosage in subsequent chemotherapy cycles or to delay radiation therapy, which may ultimately affect patient response to therapy.
An oral rinse supersaturated with calcium and phosphate is effective in reducing the duration and severity of oral mucositis in patients receiving hematopoietic stem cell transplantation (Bone Marrow Transplantation (2003) 31: 705-12). In addition, sodium bicarbonate is recognized as having the beneficial effect of reducing acidity of oral fluids, diluting accumulating mucus in the oral cavity and discouraging yeast and bacterial colonization.
MuGard® is a mucoadhesive oral wound rinse available by prescription only. It is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. The ingredients for MuGard® are purified water, glycerin, benzyl alcohol, sodium saccharin, Carbomer Homopolymer A, potassium hydroxide, citric acid, polysorbate 60 and phosphoric acid.
Caphosol® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol® is provided as Dibasic Sodium Phosphate 0.032, Monobasic Sodium Phosphate 0.009, Calcium Chloride 0.052, Sodium Chloride 0.569, Purified Water qs ad (% w/w). Caphosol® is a preparation comprising two separately pack aged aqueous solutions, a phosphate solution (Caphosol A) and a calcium solution (Caphosol B) which, when both ampule solutions are combined in equal volumes, form a solution supersaturated with respect to both calcium and phosphate ions.
NeutraSal® (supersaturated calcium phosphate rinse) is a prescription mouth rinse. NeutraSal® is indicated to treat the painful symptoms associated with oral mucositis. NeutraSal® is provided as a powder for dissolving in 30 ml water to form a supersaturated calcium phosphate rinse. The powder includes sodium, phosphates, calcium, chloride, and bicarbonate.
US20110086108 involves the formulation of stable powders which, when dissolved in water form a non-pressurized carbonated solution supersaturated with calcium and phosphate ions, and also containing the presence of carbon dioxide and sodium bicarbonate. The resulting solution is used as an oral rinse for the prevention and treatment of inflammatory processes of the soft tissues of the mouth, throat and oral cavity, which may result from infection or trauma to the oral mucosal tissue.